COVID-19 Public Health Response (Point-of-care Tests) Order 2021

Last updated: 7 October 2022

The COVID-19 Public Health Response (Point-of-care Tests) Order 2021 came into force 22 April 2021. This order prohibits a person from importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless the Director-General of Health has:

  • authorised the person’s activity; or
  • exempted the point-of-care test from the prohibition.

This order replaces the Notice Under Section 37 of the Medicines Act 1981 (Gazette 2020-go1737) and broadens the group of Point-Of-Care tests the restrictions apply to.

Per the POCT Order, a point-of-care test means any kit or other material that is intended to:

  1. be used to test for SARS-CoV-2 or COVID-19 infection or immunity (whether current or historical) in an individual; and
  2. produce a result without analysis at a laboratory

The Director-General may exempt any point-of-care test or class of point-of-care tests from the application of any or all of the prohibitions in clause 7 if the Director-General is satisfied that:

  1. the point-of-care test or class of point-of-care tests is sufficiently accurate and reliable so as not to pose a material risk to the public health response to COVID-19; and
  2. the exemption is not inconsistent with the purpose of the Act; and
  3. the exemption is no broader than is reasonably necessary to address the matters giving rise to it.

Adding a POCT device, including rapid antigen tests, to the approved Ministry of Health list

Any person may import, manufacture, supply, sell, pack, or use an exempted point-of-care rapid antigen tests without restriction under the Order. 

Rapid antigen tests that are exempted and authorised for use in New Zealand can be found under Approved RATs and how to use them.

Importation (the goods crossing the 12 nautical mile point, whether or not for use in New Zealand) of COVID-19 point-of-care tests (POCT) and devices, including rapid antigen tests, must not commence prior to the person obtaining authorisation or the device receiving an exemption from the Director-General of Health. Any attempt to do so is considered unlawful and will result in the goods being confiscated or seized.

An application needs to be submitted to be granted an authorisation or exempt a POCT from the Order and be added to the Ministry of Health approved list. To help with the assessment of whether an exempted COVID-19 point-of-care test meets the criteria set out in clause 9(1)(a) of the POCT Order, that the exempted POCT is sufficiently accurate and reliable, each application for exemption of a device is evaluated against a selection criteria and evaluation framework. The evaluation framework was endorsed on 12 November 2021. This was subsequently revised and updated on 19 January 2022 and 14 February 2022.

The evaluation is a two-stage process.

The first stage criteria are:

  1. Minimum ≥80% sensitivity and>98% specificity
  2. Evidence and data that demonstrate devices meet acceptable quality standards for source, manufacture, storage, and stability:
    • Medical device markings: Conformite Europeenne (CE) marked (manufacturer or importer affirms the goods conformity with the European health safety and environmental protection standards) or Underwriter Laboratories (UL) certification/recognised or equivalent.
    • Manufacturing facility standards: International Organizational Standard (ISO) and European standards; European Norm (EN) standards, Manufacturing Conformity, Good Manufacturing Practices, or Food and Drug Administration 21 CFR 820.
    • Real-time or accelerated stability study displaying ≥12-month shelf-life.
  3. Certification from one of the following:
    • USA Food and Drug Administration (FDA) emergency use authorisation or approval
    • United Kingdom Department of Health and Social Care (DHSC) approval (phase 3a validation)
    • Medicines and Healthcare products Regulatory Agency (MHRA) approval or exceptional use authorisation
    • WHO Emergency Use Listing for In vitro diagnostics (IVDs) Detecting SARS-CoV- 2
    • Australia’s Therapeutics Goods Administration (TGA) approval for inclusion in the Australian Register of Therapeutic Goods (ARTG)
    • European Commission Directorate-General for Health and Food Safety (common or mutual recognition list)
    • Or other equivalent comparator countries and authorising environment at the discretion of the Ministry of Health.

The applicant is responsible for supplying all required documentation to evaluate against the stage one selection criteria. Devices not meeting these criteria or applications without the information to assess the criteria will not be considered. For devices that meet the selection criteria in stage one, it will progress to a full technical assessment (stage two) for a further in-depth review.

The stage two criteria are:

  1. Equity and considerations for Te Tiriti o Waitangi
    • Usability study, training materials or videos demonstrating use, or Information for use available in multiple languages
  2. Data reporting
  3. Studies on clinical performance:
    • Inclusion:
      • Consecutive participants with clearly defined study population with no prior knowledge of COVID-19 diagnosis (i.e., ‘unselected’)
      • Report both sensitivity and specificity (or both can be calculated from a 2x2 table)
      • All participants have the index and reference test
      • Index test is a point-of-care test
      • Reference test is a gold standard nucleic acid amplification test (NAAT) preferably RT-PCR
      • Clinical performance data must meet the following thresholds:
        • Overall ≥80% sensitivity and >98% specificity (recommended by WHO, ECDC, TGA, and European Commission MDCG) compared to the gold standard RT PCR
        • ≥90% sensitivity for Ct values <25
    • Exclusion criteria:
      • Case-control studies
      • data not provided in English language
      • Studies using only stored samples of known infectious status or spiked samples (i.e., analytical performance)

For multiplex test devices, the same stage one and stage two selection criteria apply for SARS-CoV-2 and other respiratory infectious diseases.

For serology and antibody test devices, these are not considered or approved for use as a self test. Point-of-care serology and antibody test devices should be restricted to accredited pathology laboratories with appropriate clinical oversight by a medical practitioner with relevant expertise (i.e., a Clinical Pathologist). For point-of-care serology and antibody test devices, the stage two evaluation framework criteria has a higher minimum threshold for clinical performance data: 

  • Clinical sensitivity of ≥98% and a specificity of ≥98% specificity for total antibodies, only IgG, or only IgM.

All criteria must be directly addressed in your application, with each criterion supported by an original documentation and the page number where the criteria has been met. Applications with insufficient information will not be progressed.

Additional documents to support the application must include:

  • Evidence, data, or confirmation of performance against currently circulating variants in Aotearoa New Zealand
  • Packaging specifications, such as pictures, dimensions, weight, and design

When submitting your application, the following check list must also be included.

A brief literature review for any additional validation data which are not part of the submission will be conducted as part of stage two. If information found in the literature does not meet the criteria above, the device may be excluded.

It will be up to the Ministry of Health to determine if a real-time field assessment is needed to further determine real-world evidence to provide assurances the device is sufficiently accurate and reliable for use in Aotearoa New Zealand. The Ministry of Health may commission a provider to coordinate the real-time field assessments with one or more accredited diagnostic laboratories.

Based on this evaluation framework, a point-of-care device can be recommended or not recommended. If recommended for approval, the National Laboratory Testing team will seek the authorisation or exemption from the Director General of Health. If approved, it may include some conditions around the use of the product.

We aim to advise applicants on either the progress of the application, or the outcome of the application, within 25 working days of receipt. Note: The time taken to evaluate and authorise each application can vary depending on the complexities of the evidence provided, and in some cases may exceed the estimated timeframe of 25 days. Communication about applications will be limited to acknowledgement of applications and advising of the decision for the application.

For applications for POCT devices that are not recommended for import or use in Aotearoa New Zealand by the Ministry of Health, only one resubmission over a period of 3 months will be accepted. A resubmission without the requested additional documentation will be counted towards the total.

If you have any queries about applications or exemptions, please email: [email protected]

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